EzRay Air W

Unit, X-ray, Extraoral With Timer

Vatech Co., Ltd

The following data is part of a premarket notification filed by Vatech Co., Ltd with the FDA for Ezray Air W.

Pre-market Notification Details

Device IDK163705
510k NumberK163705
Device Name:EzRay Air W
ClassificationUnit, X-ray, Extraoral With Timer
Applicant Vatech Co., Ltd 13, Samsung 1-ro 2-gil Hwaseong-si,  KR 18449
ContactDaniel Kim
CorrespondentDave Kim
Mtech Group 8310 Buffalo Speedway Houston,  TX  77025
Product CodeEHD  
CFR Regulation Number872.1800 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2016-12-29
Decision Date2017-01-24
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
08800016400656 K163705 000
08800016400649 K163705 000
08800016400632 K163705 000

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